03 Nov 2018 04:00 PM - 06:00 PM(America/Vancouver)
20181103T160020181103T1800America/VancouverStandards and Experts: Knowing and Regulating Risk
In the contemporary world, regulating drugs, food products, consumer goods, and occupational hazards requires evidence. The basis on which such evidence should be considered reliable and valid gets to the heart of authoritative knowledge production. In mixed settings of regulatory bodies—a confluence of industrial, bureaucratic, legal, and academic work—how has this evidence been judged? Over the 20th century, regulators have relied on experts to protect consumers and workers from risky foods, drugs, consumer products, and occupational hazards. They have developed regulatory systems assuming that if frameworks and evidentiary standards are set correctly, reliable knowledge and protective practices will follow. Yet, time and again, risky products and exposures have resisted smooth bureaucratic control. Amidst a confluence of sometimes competing political, economic, and epistemic concerns, how have interested parties legitimated policy decisions? This panel addresses a set of questions related to knowledge for regulation such as: how standards have been used to try to ensure the reliability of data; what regulators have done when evidence was inadequate or inconclusive; how competing value systems have been negotiated; and what has happened when risks did not conform to existing classifications. The papers examine international efforts to regulate toxicological laboratory practice, fetal protection policies in the U.S. industrial workplace, and U.S. Food and Drug Administration food and drug labeling practices. The session aims to generate discussion about how risk and responsibility have been formed and reformed, what has counted as evidence, and the sometimes surprising ways power has been instantiated in bureaucratic settings.
Commentator: Erica O'Neil ( ...
Ravenna B, Third FloorHistory of Science Society 2018meeting@hssonline.org
In the contemporary world, regulating drugs, food products, consumer goods, and occupational hazards requires evidence. The basis on which such evidence should be considered reliable and valid gets to the heart of authoritative knowledge production. In mixed settings of regulatory bodies—a confluence of industrial, bureaucratic, legal, and academic work—how has this evidence been judged? Over the 20th century, regulators have relied on experts to protect consumers and workers from risky foods, drugs, consumer products, and occupational hazards. They have developed regulatory systems assuming that if frameworks and evidentiary standards are set correctly, reliable knowledge and protective practices will follow. Yet, time and again, risky products and exposures have resisted smooth bureaucratic control. Amidst a confluence of sometimes competing political, economic, and epistemic concerns, how have interested parties legitimated policy decisions? This panel addresses a set of questions related to knowledge for regulation such as: how standards have been used to try to ensure the reliability of data; what regulators have done when evidence was inadequate or inconclusive; how competing value systems have been negotiated; and what has happened when risks did not conform to existing classifications. The papers examine international efforts to regulate toxicological laboratory practice, fetal protection policies in the U.S. industrial workplace, and U.S. Food and Drug Administration food and drug labeling practices. The session aims to generate discussion about how risk and responsibility have been formed and reformed, what has counted as evidence, and the sometimes surprising ways power has been instantiated in bureaucratic settings.
Commentator: Erica O'Neil (Arizona State University)
Organized by Colleen Lanier-Christensen (Harvard University)
Regulating Chemical Risks and International Trade at the Organization for Economic Cooperation and DevelopmentView Abstract Part of Organized SessionMedicine and Health04:00 PM - 04:40 PM (America/Vancouver) 2018/11/03 23:00:00 UTC - 2018/11/03 23:40:00 UTC
In the 1970s, governments worldwide vastly expanded their pre-market review of chemical data, and with it the need for toxicological testing. Previously, such review was only required for products intended to have biological effects, such as drugs and pesticides. Legislators and regulators weighed competing priorities: assessing health and environmental risks; conserving limited testing resources; and harmonizing different national testing requirements so as not to create trade barriers that would fracture international markets. Seeking to balance these priorities, in 1981 the 24 industrialized nations of the Organization for Economic Cooperation and Development (OECD) adopted common chemical testing standards. Under the framework of “Mutual Acceptance of Data,” member governments agreed to accept all data from toxicological tests that adhered to a collectively agreed upon set of standardized test methods and strict requirements for “good laboratory practice.” All data that adhered to these standards, regardless of country of origin, would be accepted as a basis for decisions. Data that did not adhere to this framework would not be accepted; this proved to exclude most academic toxicology studies. This paper will examine how standards helped to create an international infrastructure of chemical regulation: the rules made chemical data legible to and portable among bureaucratic governments, enabling governance by distant authorities while also liberalizing international trade. OECD nations regulated laboratory practice to control market behavior, and this constrained the type of testing done and knowledge produced.
The Rise (and Fall) of the Food-Drug Line: Classification, Gatekeepers, and Spatial Mediation in U.S. Food and Health MarketsView Abstract Part of Organized SessionMedicine and Health04:40 PM - 05:20 PM (America/Vancouver) 2018/11/03 23:40:00 UTC - 2018/11/04 00:20:00 UTC
This paper explores the history of the “food-drug line” in U.S. product regulation: the classification boundary developed by public health regulators and medical professionals to demarcate medical products, with stricter safety standards, from food and dietary products normally governed by more lax, informal marketing standards. The paper will describe the American Medical Association (AMA) and U.S. Food and Drug Administration’s (FDA) 100+-year history of using product classification to allot risk decision-making in consumer food and drug markets, linking these practices to regulators’ ideas about “gatekeeper theory,” the belief that access to risky products like drugs should be mediated by expert gatekeepers such as medical doctors. The paper will focus on the debates over food and drug labeling in the 1960s prompted by several new health food trends: vitamania and industry use of vitamin-enrichment, artificial sweeteners and low-cal foods, and the “cholesterol controversy” that fueled broad interest in low-fat foods and preventive medicine. Marketing campaigns in these health foods transgressed the classification barrier the FDA and AMA sought to build between food and drug, at a time when they were trying to develop clear guidelines on prescription drugs in the wake of the thalidomide scandal. The paper examines the food-drug line, its rise and fall over the course of the twentieth-century, as an example of institutional framing linked to and shaped by changes in the ways regulatory science addresses risk and responsibility, shifting retailing environments for health products, and the evolving relationship of a consuming public to medical and regulatory experts.
Fetal Protection Policies in the Industrial WorkplaceView Abstract Part of Organized SessionMedicine and Health05:20 PM - 06:00 PM (America/Vancouver) 2018/11/04 00:20:00 UTC - 2018/11/04 01:00:00 UTC
At Johnson Controls, Inc., a car battery manufacturer, the assembly process entailed exposure to high levels of lead. After discovering that six of its female employees became pregnant while maintaining blood lead levels more than those thought safe by the Occupational Safety and Health Administration (OSHA), Johnson, in 1982, barred all its female employees, except those with medically documented infertility, from engaging in tasks that required exposure to lead. Johnson Controls’ decision was rooted in the occupational health practices of the 1950s. In the 1950s automobile manufacturers began instituting their own sex-based labor policies, beginning with a fetal protection policy that prohibited fertile women from working with lead. Neither women nor men in the automobile industry protested these policies in the 1950s. In the next twenty-five years, however, the United Auto Workers (UAW) confronted company fetal protection policies on behalf of their female and male members. The UAW filed the suit against Johnson Controls, which resulted in a 1991 Supreme Court decision disallowing such policies. This paper will examine how fetal protection policies were justified by various parties, how notions of acceptable risks (and for whom) developed and were animated by the growing number of women entering the industrial workforce and the increased medical scrutiny they received. It will also highlight the debates amongst regulatory agencies, employers and the courts that were underpinned by data on the effects of lead on women’s reproductive health but did not account for the effects on men’s reproductive health.
